News Releases
Mochida Obtains Approval for “Dinagest Tab. 1mg” - A Treatment for Endometriosis
(Tokyo, October 22, 2007) - Mochida Pharmaceutical Co., Ltd. (Head Office: Shinjuku-ku, Tokyo, Japan; President: Naoyuki Mochida) announced that it received manufacturing and marketing approval for “Dinagest Tab. 1mg” (dienogest), a therapeutic agent for endometriosis on October 19.
“Dinagest Tab. 1mg” was in-licensed from Bayer Schering Pharma AG, and has been developed as a therapeutic agent for endometriosis by Mochida in Japan. This agent shows a selective agonist action on progesterone receptors, and demonstrates oral therapeutic effect on endometriosis by inhibiting ovarian function and proliferation of endometrial cells.
Endometriosis is classically defined as the presence of tissues resembling endometrium – the mucosa lining the uterine cavity – outside the uterus, and its lesions may cause hemorrhage and inflammation along with the menstrual cycle, leading to adhesions with surrounding peritoneal tissues. The disease affects a negative impact on quality of life of women by producing symptoms such as dysmenorrhea, pelvic pain, fatigue and infertility. The number of patients with endometriosis is said to be increasing, because the disease is believed to progress with repeated menstruation and women experience shorter periods of amenorrhea due to later marriage and fewer fertilization in recent years.
Mochida Pharmaceutical is committed to improving female health, with a focus on obstetrics and gynaecology as one of its key areas. Now that “Dinagest Tab. 1mg" has been granted manufacturing and marketing approval, this novel therapeutic agent is expected to further improve quality of life of patients by offering a new treatment option for endometriosis.
The timing of product release will be announced after NHI (National Health Insurance) price listing.
For Reference
Brand Name: Dinagest Tab. 1mg
Nonproprietary name: Dienogest
Indication: Endometriosis
Ingredients and Contents: 1 mg dienogest per tablet
Dosage and Administration: Usually, to adults, 2 mg of dienogest is orally administered daily in 2 divided doses, starting from day 2-5 of the menstrual cycle.
Date of Approval: October 19, 2007
Manufacturer/Distributor: Mochida Pharmaceutical Co., Ltd.